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NCT02052778 · OUTCOME

Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits

A Study of TAS-120 in Patients With Advanced Solid Tumors · Source last updated 2025-03-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])

What was measured

EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.

Analysis population: Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.

Groups in this outcome

Phase 2

Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 292

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Phase 290

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 282Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 28Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Phase 281

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 275Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 26Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Phase 278

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 270Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 27Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Phase 265

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 258Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 26Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported
Cycle 10

Analysis denominator · Participants

GroupSource count
Phase 258

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 252Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 25Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported
Cycle 13

Analysis denominator · Participants

GroupSource count
Phase 247

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 241Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 26Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 16

Analysis denominator · Participants

GroupSource count
Phase 235

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 230Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 24Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported
Cycle 19

Analysis denominator · Participants

GroupSource count
Phase 228

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 222Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 26Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 22

Analysis denominator · Participants

GroupSource count
Phase 221

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 218Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 23Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 25

Analysis denominator · Participants

GroupSource count
Phase 212

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 29Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 23Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 28

Analysis denominator · Participants

GroupSource count
Phase 28

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 28Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 31

Analysis denominator · Participants

GroupSource count
Phase 23

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 23Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 34

Analysis denominator · Participants

GroupSource count
Phase 23

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 23Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 37

Analysis denominator · Participants

GroupSource count
Phase 23

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 22Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
Cycle 40

Analysis denominator · Participants

GroupSource count
Phase 21

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 20Not reportedNot reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
Phase 243

No Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 234Not reportedNot reportedNot reportedNot reported

Some Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 28Not reportedNot reportedNot reportedNot reported

Extreme Problem

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        82
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        75
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        6
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        70
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        7
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        6
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      units
      Participants
    title
    Cycle 7
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        52
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        5
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Cycle 10
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        6
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    Cycle 13
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        4
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    Cycle 16
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        6
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Cycle 19
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        3
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    Cycle 22
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        3
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Cycle 25
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 28
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      title
      No Problem
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Some Problem
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Extreme Problem
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 31
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    units
    Participants
description
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was rated on 3 levels of function: no problem, some problem and extreme problem. In this outcome measure, data were reported categorically as the number of participants who chose each category.
groups
  1. description
    Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG000
    title
    Phase 2
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
title
Phase 2: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Self-care Scores at Specified Visits
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice